The medical condition to be investigated in this study is atopic eczema, also known as atopic dermatitis. MedDRA version: 20.0 Level: LLT Classification code 10003641 Term: Atopic eczema System Organ Class: 100000004858
Conditions
Interventions
Product Name: NIAD Gel
Pharmaceutical Form: Gel
INN or Proposed INN: Nicotinamide
CAS Number: 98-92-0
Concentration unit: % (W/W) percen
Sponsors
Dermal Laboratories Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i) Male or female patients aged 16 years or older. ii) Diagnosed as having atopic eczema as determined according to the UK Working Party's Diagnostic Criteria. iii) Experiencing a mild to moderate acute episode (or flare) including bilaterally symmetrical involvement of the volar aspects of the forearms (including the flexures), presenting a local Investigator Global Assessment (IGA) score of 2 or 3 (see section 1.9) and an involvement area of at least 20 to 25 cm2 (approximately half of the size of a credit card). iv) Willing to refrain from using any other topical treatments as well as emollients or moisturisers on the entire area of the volar forearms (from the front of the wrists to just above the creases of the elbows) for the next 29 days. Patients will be permitted to continue using prescribed topical treatments required for managing atopic eczema (including topical immunosuppressants) in other non-study areas of the body. Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: i) Patients with a history of intolerance or skin sensitivity to any of the ingredients. ii) Patients with systemic diseases which, in the opinion of the Investigator, may adversely influence their participation in the trial. iii) Patients with severe atopic eczema (IGA=4) and/or with any active skin infections in the selected target areas. iv) Patients with more than 20% of total body surface area of involvement (i.e. area equivalent to the whole of both arms or the whole of one leg). v) Patients who have had phototherapy (UVB, PUVA) or systemic therapy with corticosteroids and / or other immunosuppressants, or cytostatics, within 4 weeks prior to screening. vi) Patients who have taken systemic antibiotics within 2 weeks prior to screening. vii) Patients who have applied topical treatments (e.g. tar, corticosteroids) on the study areas within 7 days prior to screening (with the exception of topically applied emollients). viii) Patients receiving other medication known to alter the course of atopic eczema during the study (e.g. oral corticosteroids and/or other oral immunosuppressants). ix) Patients who have received any unlicensed drug within the last 30 days or who are scheduled to receive an investigative drug other than the study medication during the period of the study. x) Female patients who are pregnant, attempting to conceive or not currently using a contraceptive, or lactating (although there are no particular safety concerns in these patient groups, it is generally inappropriate for them to participate in clinical trials without overriding justification. Negative pregnancy testing will not be necessary, and there are no safety concerns, as such, about female subjects potentially conceiving while taking part in the study). xi) Patients considered unable or unlikely to attend the necessary follow-up visits. xii) Patients with another member of the household already enrolled in the study (this is to avoid possible mix up between assigned treatments). xiii) Patients with tattoos, scars and/or birthmarks on the study treatment areas, which could potentially interfere with the visual assessments and/or the objective skin measurements performed in this study. xiv) Patients with temporary or permanent impaired function of either left or right hands/arms such that they would be unable to apply the test products correctly to both arms themselves, and who cannot rely on external help (e.g. a relative or carer) to do so for them. xv) Employees of Alba Science or Dermal Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of such employees.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is essentially a proof of concept study to find out whether the 4% nicotinamide gel offers therapeutically relevant treatment of mild to moderate atopic eczema. If the active gel is beneficial in treating the very itchy, red and inflamed ‘flared’ atopic eczema skin areas, this may help us develop a new product which can help reduce the impact of atopic eczema on the lives of patients and their families. ; Secondary Objective: We are interested in gathering as much information as possible about how the study gels affect the skin of patients with atopic eczema. For this reason, several secondary clinical outcomes, as well as additional clinical outcomes, comprising measures of local flare severity and the patient self-reported assessment of itchiness on the treated areas of the inner forearms, are also included in this trial. Additional patient reported outcomes are also included in order to collect feedback from the patients themselves regarding their satisfaction with the physical aspects of the study gels, or not as the case may be. This is a very important aspect of any topically applied medicine; especially for a chronic condition such as atopic eczema. The research methodology being employed in this study also includes a number of exploratory outcomes evaluating the effects of the study gels on the skin barrier function, aiming to provide a better understanding of the mode of action of the active ;Primary end point(s): The primary outcome measure for the study will be the difference between the change from baseline in the Investigator Global Assessment (IGA) for the area treated with the active gel compared to the area treated with the placebo gel, at the end of the 4 week treatment period. IGA will be scored by the Investigator using the following 6 point scoring system: 0 = absent; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe; 5 = very severe | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Three Item Severity Score (TISS) This secondary efficacy parameter will be the change from baseline in the TISS, which is the sum of the three individual SCORAD intensity scores of erythema, oedema/papulation and excoriation at the end of the 4 week treatment period for the areas treated with the active gel compared with the placebo treated areas. Each of these SCORAD intensity items will be scored by the Investigator using the following 4 point scoring system: 0 = absent; 1 = mild; 2 = moderate; 3 = severe. 2. Percentage of patients with Investigator Global Assessment (IGA) of 0 (clear) or 1 (almost clear) For this secondary outcome, the Investigator will calculate the percentage of patients with Investigator Global Assessment (IGA) of 0 (clear) or 1 (almost clear) at the end of the 4 week treatment period for the areas treated with the active gel compared with the placebo. The IGA will be assessed by the Investigator on the treated forearms as primary efficacy parameter for this trial. 3. Patient self-assessment of pruritus This secondary outcome refers to the change from baseline in patient self-assessment of pruritus at the end of the 4 week treatment period for the areas treated with the active gel compared with the placebo treated areas. Patients will grade the intensity of pruritus on each treatment area using the following 6 point categorical scale: 0 = none; 1 = mild; 2 = moderate; 3 = marked; 4 = severe; 5 = intense. 4. Patient self-assessment of relative itchiness This is related to the percentage of blinded patients reporting that the area treated with the active gel was less itchy than the area treated with the placebo gel, at the end of the 4 week treatment period. Patients will be asked to compare the degree of itching between the two left / right areas on a 5 point comparative scale: 1 = the left side study are | — |
Countries
United Kingdom
Contacts
Public ContactAmanda Wigens
Dermal Laboratories Limited
Outcome results
None listed